Race for a world-beating bionic eye

For those of us with sight it is hard to imagine what it would be like to have no perception of light, yet blindness is a blight that afflicts thousands of Australians. While it is said that other senses – hearing, smell and touch – become heightened to compensate for blackness, that is not stopping the first eager volunteers from lining up to test Australian technology to find out if it will let them see again.

They are finding their way to research laboratories in Sydney, Melbourne and Canberra, where a $42 million research project funded by the federal government aims to repeat for vision the nation’s success with the Cochlear bionic ear.

“A lot of the early work is being done in animal trials and in vitro [in the laboratory]," says Robert Shepherd, the leader of the Bionic Vision Australia (BVA) project.

“We have to make sure the technology we implant in patients is safe and we are not causing any additional damage to the eye structures. The first patients will be brave types, as they will not receive a lot of useful benefits themselves in the early stages of the project."

In a project that mimics the implantation of the first bionic ear in 1978, new Australian Research Council funding has brought together surgeons, electronics engineers and psychologists who aim to implant the first vision device in 2013.

The first patients will have become blind through advanced retinal disease – sight is so precious that only they will have the most to gain and the least to lose should things go wrong.

They also need to have realistic expectations of the result as they may be hit hard psychologically if the procedure were to fail.

Leading the search, Shepherd heads both BVA and Victoria’s Bionic Ear Institute, which is competing against perhaps a dozen overseas groups – including some that have already implanted their first bionic eye prototypes.

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“This is an area where Australia is highly regarded on the world stage," Shepherd says.

“We have probably the leading medical device company in the world in Cochlear. Our task is to be able to continue to develop that technology."

The global scientific competition involves slightly different approaches. The Australian concept is based on a camera and image processor mounted in a pair of spectacles. Electronic signals will be broadcast to an implant and, finally, a computer chip and a multiple-electrode neuro-stimulator implanted in the eye.

The first thing you notice about the Australian team is an almost nonchalant confidence in success.

Most cut their teeth scientifically developing and improving the bionic ear and spent 14 years in university-funded projects transferring that technology to the much more complicated problem of sight.

Now the government funding has accelerated their efforts.

“We will solve getting something into the eye that works," lead surgeon
Robyn Guymer
says. “I am sure we will do it, but it may take longer [than many hope] before someone sees significantly better than before."

Guymer leads a team at the Royal Victorian Eye & Ear Hospital in Melbourne that is working to gain experience and build up their skills. Her background is general eye surgery; others specialise in cataract surgery. Ultimately the most experienced surgeon will perform the first operation.

Guymer already understands a lot about implanting the tiny packages of electronics that make up the bionic eye from decades of work on the bionic ear.

The first problem that has been solved is where to place the device in the eye, a part of the body that is highly mobile. The team has chosen a natural pocket of tissue on the choroid, a network of blood vessels immediately behind the retina.

“This is the easiest location," Guymer says.

“You don’t have to go into the eye itself, but rather you go behind the eye. Anything in the eye has a lot of risk associated with it and potential for disaster."

But Guymer knows risks need to be balanced against benefits. The bionic eye has to make the experience of living a lot better than it now is.

“The challenge is to get the device to work in a way which adds significant value to people," she says.

“The very first device is going to give navigational vision, the ability to move around independently. More will come later."

Patients will not initially be able to perceive a complete scene as most of us do, although they will likely tell night from day and see bright lights, sense very large objects such as buses, and detect edges such as the sides of buildings or gutters.

The challenge is the sheer amount of information the brain needs to build up a scene compared with the simpler perception of hearing.

At the University of NSW, engineer
Gregg Suaning
leads a 15-member team developing the neuro-stimulator that will stimulate the optic nerve with electricity and the silicon chip that will control it.

The 22 electrodes in the Cochlear device are enough to help the deaf to hear different accents and even enjoy music, but the initial BVA implant will be five times as large and made up of 100 electrodes arranged in a square array, 10 electrodes by 10.

A second team at the University of Melbourne is developing a separate, 1000-electrode device that will form the heart of a more complex second-generation bionic eye. This will be implanted within the eye itself, directly stimulating the optic nerve.

“I think what we are doing is smart,“ Suaning says. “We are pursuing two lines of research at the same time – one a little more risky than the other."

Suaning has developed a novel manufacturing technique for making the array made up of 100 electrodes complete with 100 connecting wires that link it to an implantable chip. He takes an ultra-thin sheet of platinum and cuts out the tiny electrodes and wires using a high-precision laser. Sealed by layers of common silicone, the resulting electrode package weighs a fraction of a gram and even with the wires is less than 22 millimetres long.

“If we want to finish we have to have a realistic approach that is feasible," Suaning says.

“We have the technology to do each part. But it is the putting together of all the individual parts that is a challenge."

A key discipline is retaining the technical strengths that helped Cochlear fight off better-funded competition from companies such as the giant 3M.

The Cochlear device was the first electronics implant to be reliably hermetically sealed and it did not suffer the quality problems that still plague its competitors. Suaning feels excitement building as the team closes in on what, until recently, was a fanciful scientific dream.

“This is the thing I want to do in my career," Suaning says. “I want to be able to allow people who don’t see to see something. Before, we could always say we didn’t have enough money. That excuse is gone. If it doesn’t happen it will be our own fault."

Even the best electronics and surgical techniques are only the beginning of the bionic eye challenge – the brain still has to be able to interpret the electrical stimulation as sight.

“When you put an electrical stimulation into an organ like the eye or an ear it stimulates nerves directly," says psycho-physicist
Peter Blamey
. “But it is not known what perceptual effect that’s going to have on the brain."

Blamey works at the Bionic Ear Institute, which has long been working on the two types of stimulation possible within the ear. In the bionic ear, moving a point of stimulation along the aural nerve is perceived as a steadily rising frequency of sound. Changing the rate of stimulation changes the perceived pitch.

“There were some big problems in the early days [of the bionic ear]," Blamey says. “Loudness was uncontrollable. We had to learn to control the way we stimulated the electrodes one at a time."

Initially the BVA task will be to understand what parts of the thousands of nerves in the eye are sensitive to electrical stimulation. At first the team will use only one electrode to stimulate a single point on the optic nerve.

“We think it is going to look like a localised bright spot on a dark background," says Blamey. “It will be like looking at a bright light in a dark room. We should be able to control the brightness of the spot by controlling the amount of current. But we are not sure how big the light will appear or what shape it will be."

By working closely with the patients, Blamey will build up a picture of what they perceive with different patterns of stimulation. Some parts of the eye respond to colours, others to edges or lines and others to dots. The brain puts all this information together to perceive a face or an object.

The knowledge built up will be used to create the processing software which will determine what part of the signal from the video camera will be selected to be coded and transmitted to the implant.

By stimulating more and more of the 100 electrodes the plan is that a picture will gradually be built up made up of individual spots or pixels of light.

“We need to make a map of the positions where the spots of light seem to appear in the patient’s brain," Blamey says. “They may be different from one patient to another. That would mean potentially the bionic eye will have to be programmed individually."

Despite scientific progress, the scientists are realistic about what will be achieved initially. While most people perceive a field of view equating to an angle of 180 degrees of the environment, the bionic eye will have a far smaller angle. It will be like looking down a tube at a black and white world. Even moving to the 1000-electrode implant will not necessarily increase the field of view but will increase the resolution of the image. It should be possible with the second-generation device to recognise a face or read large print.

There is a good deal of confidence that BVA can solve what are big technical issues, but Canberra has taken out insurance by funding a smaller bionic eye project at Monash University in Melbourne. Both teams understand that the bionic eye needs to be taken on by an entrepreneurial company to truly succeed.

Cochlear
chief executive
Chris Roberts
says entrepreneurs were the key to the success of Australia’s two leading medical device companies, his own and sleep disorder business
ResMed
. The late Paul Trainor drove the success of Cochlear and
Peter Farrell
was the driving force behind ResMed.

Farrell was originally a professor of biomedical engineering in the same laboratory at UNSW in which Suaning works today.

He still takes a keen interest in the Australian medical device sector, which is made up of 600 mainly small companies. But they make up a disappointing 0.6 per cent of the global device market, according to Austrade.

Farrell believes ResMed’s success in taking esoteric sleep science to the commercial world is “opportunistic" and has concerns about the innovative environment in Australia for such businesses.

“I think there are more ResMeds and Cochlears in the Australian hopper, somewhere," he says. “But the system is not set up to grease the way, if you like."

Although there is, as yet, no commercial structure around BVA, there are other corporate players close to the project who could come into play later.

These include
Gerry Moriarty
, a former Telstra technology executive who is now deputy chairman of the
Macquarie Communications Infrastructure Group
.

But the project is still with the scientists and they face well-funded competitors who have a head-start. Much faith is being placed on the skills and experience drawn from the bionic ear. But Robert Shepherd himself understands that his team is on a long and arduous journey.

“There are competitors both in the research lab and commercially," Shepherd says.

“It is a bit like the Olympics – it is all building excellence and competition. I am sure we will get where we want to be."